Regulatory Communications

“For FDA Advisory Committee meetings, CMG's broad knowledge and experience have been instrumental in helping to prepare spokespeople, presenters and external experts to deliver credible, compelling and accurate information. Colleen has an incredible command of complex issues and subject matter.”

Julissa Viana, Director, Communications / Marketing, Sepracor Inc.

REGULATORY COMMUNICATIONS

A key advantage to working with CMG PRODUCTIONS is our proven ability to execute a comprehensive communications program for any regulatory communication, whether that involves message development, presentation preparation, Q&A management or media interview anticipation and practice. To that end, our expertise can be deployed in a number of strategic forms to most efficiently prepare the entire team - external and internal - for U.S. and European regulatory interactions.

  • MESSAGE STRATEGY & MAPPING

    To ensure the Sponsor presentation meets the Advisory Committee expectations, early consensus on the Key Messages and the Story Flow are pivotal for a successful preparation process.

    CMG specializes in facilitating the translation of complex information into a story that is accessible, credible and customized for regulatory audiences. To prepare for various potential scenarios during the Advisory Committee meeting, CMG facilitates a Message Strategy Workshop to build consensus on Messages and the Story Flow. In addition, participants have the opportunity to identify key issues that will need to be addressed during the Advisory Committee interactions.

  • ISSUES MANAGEMENT

    In preparation for an FDA or CHMP Advisory Committee Meeting, a strategic scenario-driven approach is taken that anticipates the various issues the Committee may raise in the course of the meeting as well as potential decision outcomes. The key to successful preparation includes not only well-executed presentations but also the ability to manage Q&A and address "thorny" topics, i.e., the ability to manage issues. Issues Management sessions are conducted with both the internal and external experts - as well as external KOLs who may be called upon at the meeting and/or by the media - to ensure clear and consistent message delivery.

  • SPONSOR SPEAKER READINESS

    To ensure the Sponsor's story is coherent, concise and persuasive, customized Speaker Readiness sessions are organized to "pressure test" the message and enhance delivery. In addition, Advance Mock Panels may be convened to ensure smooth presentation delivery. Special emphasis is placed on Q&A rehearsal and consistent message delivery.

    The Workshop focuses on:
    • Anticipating the Audience Demand
    • Creating an Agenda
    • Mapping the Story
    • Preparing for Difficult Questions
    • Organizing Speaking Points
    • Managing Questions
    • Utilizing Support Materials
    The session may be organized one-on-one or as a Group Communications Workshop and may be combined with a Strategic Positioning or Message Mapping Workshop.

  • Q&A "PRESSURE TESTING"

    More than one Advisory Committee meeting has been "lost" due to inadequate preparation for the Q&A process. In order to ensure that every question that might be posed by a Committee member is adequately anticipated and most effectively addressed, Q&A "Pressure Testing" Workshops are organized to simulate the regulatory setting and enable practice delivering messages and utilizing support slides.

    CMG specializes in facilitating the translation of complex information into responses that are accessible, credible and customized for the regulatory audience.

  • KOL READINESS

    In conjunction with Sponsor preparation, Key Opinion Leaders may be engaged to prepare for the Advisory Committee process, either as a presenter, mock panelist or for a media interview opportunity.

    CMG specializes in facilitating the translation of complex information into a story that is accessible, credible and customized for particular audiences, such as the KOL's peers at an FDA Advisory Committee Meeting. Many experts fall into the trap of The Expert's Dilemma: believing that more information will add to understanding. Yet, rather than creating clarity, the expert creates confusion instead.

    The KOL Readiness process is customized based upon the KOL's needs and may include:
    • Message Mapping
    • Speaker Readiness
    • Media Strategy & Skills

  • MEDIA STRATEGY & SKILLS

    In order to prepare for media coverage of the Advisory Meetings, a custom designed Media Strategy and Skills Workshop is designed for company spokespersons and KOLs.

    During the Workshop, the participants are prepared to deliver key messages, even in the context of potentially hostile situations, to reporters during a range of interviews, including taped and live broadcasts as well as print and wire service encounters.

    Various interview settings that participants are likely to encounter are simulated and videotaped so that they become comfortable with the technical requirements of in-studio interviews and to provide an opportunity for videotape playback. The participants' performance is evaluated with intensive feedback on message delivery, demeanor and overall effectiveness.

    The session may be organized one-on-one or as a Group Communications Workshop and may be combined with a Strategic Positioning or Message Mapping Workshop.